Method for treating joint damage
Inventors
Totoritis, Mark • Shaw, Timothy Mark • Agarwal, Sunil • Yocum, David • Kelman, Ariella
Assignees
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Publication Number
US-10654940-B2
Publication Date
2020-05-19
Expiration Date
Abstract
Methods of treating joint damage in a subject eligible for treatment are provided involving administering an antagonist that binds to a B-cell surface marker, such as CD20 antibody, to the subject in an amount effective to slow progression of the joint damage as measured by radiography. Further provided are articles of manufacture useful for such methods.
Core Innovation
The invention relates to treating joint damage caused by rheumatoid arthritis in a subject with inadequate response to one or more antitumor necrosis factor (TNF) inhibitors, using a CD20-binding antagonist such as rituximab or humanized 2H7. The method addresses active disease and structural joint damage progression, and uses the outcome of structural joint damage to evaluate efficacy.
The disclosed method includes a prior course of treatment with two 1000 mg intravenous doses of rituximab given 14 days apart, followed by a further course of two 1000 mg intravenous doses of rituximab given 14 days apart within weeks 24 to 40. The subject has responded to the prior course, and the treatment aims to slow or halt progression of structural joint damage for at least about 52 weeks.
The disclosure further relates to repeat radiography and re-treatment decision concepts used to evaluate progression of joint damage over time. Radiographic endpoints include Sharp-Genant total score, erosion score, and joint space narrowing (JSN), with repeat radiography at approximately 1 month and at about 52-week endpoints.
Claims Coverage
The claim coverage identifies one core re-treatment inventive concept with dependent refinements. It centers on a subject with rheumatoid arthritis and inadequate response to one or more TNF inhibitors, previously responsive to rituximab, receiving a further rituximab course within a defined weeks 24 to 40 window to slow or halt structural joint damage progression for at least about 52 weeks.
Re-treatment rituximab course for active rheumatoid arthritis joint damage after TNF inhibitor inadequate response
Treating joint damage caused by rheumatoid arthritis in a subject with inadequate response to one or more TNF inhibitors, where the subject previously responded to a course of two 1000 mg IV doses of rituximab given 14 days apart, and the treatment comprises administering a further course of two 1000 mg IV doses of rituximab given 14 days apart at weeks 24 to 40 to slow or halt progression of structural joint damage for at least about 52 weeks.
Administration timing at about week 24
The further course is administered at about week 24 within the weeks 24 to 40 window.
Concomitant methotrexate administration
The method further includes administering methotrexate (MTX) to the subject.
Corticosteroid administered before each rituximab administration
The method further includes administering a corticosteroid to the subject before each rituximab administration.
Overall, the claims focus on re-dosing rituximab for active rheumatoid arthritis joint damage in subjects who previously responded and then had inadequate response to TNF inhibitors, using a specified weeks 24 to 40 re-treatment schedule to achieve slowing or halting of structural joint damage progression for at least about 52 weeks, with dependent refinements adding timing, methotrexate, and corticosteroid pre-administration.
Stated Advantages
Slows or halts progression of structural joint damage for at least about 52 weeks.
Documented Applications
Treatment of joint damage caused by rheumatoid arthritis in a subject with active disease after inadequate response to one or more TNF inhibitors and prior response to rituximab.
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